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Hemodynamic Effects of Rolofylline in the Treatment of Patients With Heart Failure (7418-503)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00729222
First Posted: August 7, 2008
Last Update Posted: October 20, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
NovaCardia, Inc.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  Purpose
The study will estimate the effects of rolofylline, alone and in addition to loop diuretic therapy on pulmonary capillary wedge pressure and other hemodynamic parameters, in patients with heart failure and renal impairment.

Condition Intervention Phase
Heart Failure Drug: Comparator: Placebo Drug: rolofylline Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Hemodynamic Effects of Rolofylline Injectable Emulsion in the Treatment of Patients With Heart Failure

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • change in pulmonary capillary wedge pressure [ Time Frame: from baseline to 4 and 8 hours ]

Secondary Outcome Measures:
  • Change in cardiac output, systemic vascular resistance, pulmonary vascular resistance, pulmonary pressure and right atrial pressure [ Time Frame: from baseline to 4 and 8 hours ]

Enrollment: 60
Study Start Date: November 2008
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
Placebo
Drug: Comparator: Placebo
rolofylline placebo IV infusion over 4 hours.
Experimental: 2
rolofylline
Drug: rolofylline
rolofylline 30 mg IV infusion over 4 hours.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with heart failure and renal impairment, currently using furosemide, with systolic blood pressure >95 mm Hg

Exclusion Criteria:

  • Patient has active infection, use of diuretic within 3 hours of screening visit, has acute tubular necrosis or severe pulmonary disease, any heart problems within the last two weeks
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00729222


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
NovaCardia, Inc.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00729222     History of Changes
Other Study ID Numbers: 7418-503
MK7418-503
2008_532
First Submitted: August 5, 2008
First Posted: August 7, 2008
Last Update Posted: October 20, 2015
Last Verified: October 2015

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Rolofylline
Diuretics
Natriuretic Agents
Physiological Effects of Drugs